Firefly

phototherapy

User Manual
MD Infant Phototherapy for Jaundice Treatment
# Firefly
UDI 111720641527 2265
Effective date: October 2023
Issue Number: 01 Version: 14 EN
Issue Date: October 2023 www.mtts-asia.com Firefly. User manual
 Contents

Company Information 04

Introduction 05

Quick start guide

- Components 06

- Power supply 07

- Control panel 08

Warnings 10

Battery backup (optional) 12

Safety information 14

Cleaning and disinfection 17

Irradiance measurement 18

Irradiance measurement criteria 19

Specifications 20

Explanation of Symbols 22

Warranty Policy 23

V.1.14.EN Firefly. User manual

03
 Company Information Introduction

Intended use
The Firefly Phototherapy is intended to provide phototherapy to treat infants jaundice
when a phototherapy is required and prescribed by a physician.

What does phototherapy do?

Reduces the bilirubin level in the blood through:
Photo-oxidation
MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co., LTD
Configurational isomerisation
House No. 26, Alley 41, An Duong Vuong Street, Tay Ho District, Hanoi City, Vietnam
SRN: VN-MF-000036669
Structural isomerisation

Tel: +84 24 3766 6521 Phototherapy starts medical treatment immediately after it’s turned on.
Fax: +84 24 3718 8050 It emits very little heat because of the LED light source, so does not cause
Email: assistance@mtts-asia.com dehydration.
www.mtts-asia.com
Phototherapy with Firefly
Firefly double-sided LED phototherapy equips you to deliver high-intensity
phototherapy to treat this potentially hazardous condition.
Logic s.r.l.
Via Antonio Pigafetta 1
34147 Trieste, Italy
SRN: IT-AR-000012301

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05
 Components Power Supply

3
4

5
12 V (DC)
1. Top Light
Blue light shines onto the top-side of the patient.

2. Bassinet
A removable plastic bassinet is used to carry the patient and hold the patient during
treatment.
Plug in and Power up
3. Control Panel
ON / OFF button and the display, which shows treatment time and total device hours. The connector plugs into the back of the Firefly
and then directly into the power outlet in the wall.
4. Lower Light 100 - 240 V (AC)
Blue light shines through a window onto the under-side of the patient.
Only use the cable and connector that is provided by MTTS.
5. Heat sink
Heat from the LED light source escapes from below the Firefly, ensuring the device The Firefly should only be used with the power outlets that have a
remains at a safe operating temperature. protective earth (ground) pin.

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 Control Panel Control Panel

1. Plug in the Firefly.

The device recognises the connection

by illuminating every LED on the Control
Panel display.

This will be displayed for just a few

moments before returning to a blank
screen.

2. Turn on the Firefly.

C C

The display shows the “total device hours”

The “total device hours” is a multiple of 10
of what is actually displayed.

The control panel is located at the front of the Firefly device. This will be displayed for 3 seconds.
The image above shows the control panel, which consists of: This example shows;
17 500 hours

1. Power button
Turns the device ON and OFF. 3. The blue phototherapy lights will now
start to shine.
2. Display
The display will start counting the
Shows the ‘treatment time’, as well as ‘total device hours’ of Firefly usage. “treatment time”.

This example shows;

1 minute

C C
1
C
2
C
4. The phototherapy treatment will continue
until the doctor decides therapy is no
longer necessary and the device can
be switched OFF.

This example shows;

72 hours 30 minutes

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 Warnings Warnings

Error messages: In the case that the Firefly has a minor error then the LED lifetime warning: The blue LEDs in the Firefly are rated to provide
error number will be displayed on the control panel. effective treatment for 60,000 hours.

If such an error occurs, this message will appear for 5 seconds after the device is
connected to the power supply but before the Firefly is switched on.

The Firefly is still safe to operate, however please contact MTTS and quote the error
number and device serial number. This error number will help the MTTS technical
team identify and solve the problem.
After turning ON the Firefly the display will show the “total device hours”
This particular example shows 60,000 hours.

C C

At 60,000 hours and anytime after 60,000 hours E04 code will be displayed.
This indicates that the LED’s have reached the recommended life span.
This message will appear for 5 seconds after the device is switched on following
total number of hours displayed for 3 seconds. After that E04 and total number of
hours will alternate 1 second each. C C

C The image above shows when exactly in the ‘start-up’ process the error message will be displayed.
C
General warning: In the rare occurrence that the Firefly experiences a more
serious error which results in the blue lights to “turn-off”, then immediately The blue phototherapy lights will turn ON and the treatment will start as normal.

C
remove the patient from the device, as they will not be receiving any The display will show the “treatment time” again.
phototherapy. An error code will be shown on the display panel, this error C will
Note: The estimated 60,000 hour life span is equal to a full 5 years of non-stop use. After this period of time the LED
most likely correct itself and the Firefly will automatically turn back on and
C
resume therapy, if not please contact MTTS and report the errorC code to MTTS.
phototherapy lights will continue to function, however treatment will be significantly less effective and the Firefly
should be replaced.

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11
 Battery backup (optional) Battery backup (optional)
C C

Battery Backup E-MODE - extended battery operation

The battery backup allows operating the device for 2 hours without AC power supply. E-mode allows using the battery for extended period of time (additional 2 hours).
The backup activates automatically as soon as the AC power supply is off. During that time the battery is discharged further.

To check the battery charge level press (do not hold) ‘power button’. To activate the ‘E-mode’ press ‘power button’ during the 50 second low battery
‘C:XXX’ = charge (c) percentage (xxx) alarm.
The dot after the last digit indicates charging (connected to AC power source)

To protect the batteries and prolong their life time E-mode should be used only
in emergency situations.

This example shows battery charge This example shows battery charge
level 20% and charging Cnot chargingC
level 95% and

C C
When battery charge level goes down to zero (C: 0), visual and audio alarm goes off.
The message displayed is:

Treatment time: 3 sec ‘Low’: 1 sec ‘Battery’: 1 sec

The alarm continues for 50 second and there is no action, the devices powers off.
If during the duration of the alarm ‘power button’ is pressed, the alarm is muted and
the device enters the E-mode.

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 Safety Information
When using Firefly phototherapy the patient should ALWAYS be placed in the
bassinet.
The Firefly has been designed so that the bassinet is removable.
The patient should be placed in the bassinet then the bassinet into the device
to ensure patient comfort and safety.
DO NOT carry the Firefly while the patient is in the device.
DO NOT place the patient directly on the window of the lower light.
DO NOT place the Firefly inside an incubator.
DO NOT use Firefly phototherapy with an MTTS infant warmer, or any other
warmer as this will cause damage to the Firefly top light.
14 V.1.14.EN
Safety Information
Always cover the patients eye’s with a shield or patch whenever the patients
eye’s can be exposed to the Firefly’s light. Periodically, you may want to
ensure that the baby’s eyes are protected and infection free.
Patient’s bilirubin values should be measured regularly while undergoing
phototherapy treatment.
To accurately assess the baby’s skin colour turn off the light when checking
the baby’s condition.
Regularly monitor the patient’s temperature and fluid status.
DO NOT disassemble any part of the Firefly phototherapy
(excluding the removal of the bassinet).
DO NOT place the Firefly in direct sunlight.
Note: In the event of a power outage, eye coverings should be left on the patient whenever they are inside
the Firefly to protect the patient’s eyes in case the power returns.
Firefly. User manual
15
 Safety information Cleaning and disinfection

The Firefly phototherapy should be used only by appropriately trained The Firefly bassinet should be disinfected, before and after the treatment of
personnel and under the direction of qualified medical personnel familiar with each patient. In the case that a patient undergoes treatment for more than one
currently known risks and benefits of infant phototherapy equipment use. week then be sure to disinfect the bassinet once a week.

Patients adjacent to the infant phototherapy equipment may need to be
protected with protective shields or eye protection.
The operator may experience some effects during prolonged exposure to the
area irradiated by the infant phototherapy equipment.*
Blue light can hinder clinical observations by masking skin colour changes,
such as cyanosis.
An infant’s water balance may be influenced by phototherapy. Regular feeding
times may need to occur more often in order to prevent dehydration.
Varying the ambient conditions (ambient temperature and/or different radiation
sources) may negatively affect the patient. Refer to your hospital phototherapy
policy and procedure regarding appropriate ambient conditions.
If visibly soiled, clean the affected parts with soap and water using a soft cloth.
Then wipe with a wet cloth and dry with a soft cloth. For difficult areas use a
standard soft-bristled brush.
To loosen heavy, dried-on soil, you may first need to saturate the spot with
water.
Only disinfect the bassinet with a solution containing at least 70% alcohol.
Apply the disinfectant with a clean cloth or soft sponge. Wait for the device to
dry after cleaning or disinfecting before use.
When cleaning the device disconnect the power cord.

Bilirubin photoisomers may be toxic.

Do not use the Firefly if it appears that any part of the device is not functioning
properly or if any parts appear damaged. Contact MTTS.

In case of any malfunction DO NOT attempt to service this machine,

the Firefly should only be serviced by a qualified MTTS technician.

Due to photo effects, drugs and infusion liquids should not be stored in the
radiation area.

Do not use the in the presence of potentially combustible gases including

oxygen, nitrous oxide or other anaesthetics.

*Sensitive individuals may experience headache, nausea or mild vertigo if he/she stays too long in the
illuminated area. Using the Firefly in a well-lighted area or wearing glasses with yellow lenses can alleviate
potential effects. Guard Dog Bones glass es (p/n 413BB) are recommended and are available online at
www.safetyglasses.com DO NOT use alcohol to disinfect any other part of the device.

DO NOT immerse any part of the device in water or alcohol.

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 Irradiance measurement Irradiance measurement criteria

Note: to ensure that the device is functioning properly, regularly monitor the Firefly in The lights will decay gradually over time, reaching approximately 70% of their
the following way. original irradiance at 60,000 hours.

Measurement instructions: Note that the irradiance should be measured when the device has reached 60,000
hours. After 60,000 hours the device should be replaced with a new one.
To test the irradiance of the Firefly measure using a lightmeter specifically designed
to measure wavelengths for phototherapy, preferably double sided such as MTTS LM-
800.
48cm
(18.89 in)

A stabilization time of 2 hours of continuous operation is required for accurate

measuring of the irradiance.
26 37 39 38 35 25
Measure each of the sections of the bassinet seen in the adjacent picture. Compare
the measurements to the expected values assuming some decay over time. 20cm
(7.87 in)
25 35 37 39 35 25

TOP LIGHT
IRRADIANCE
μW/cm2/nm

20.0 - 34.9
35.0 - 49.9
50.0 - 64.9
BOTTOM LIGHT

42 63 61 57 62 44

20cm
(7.87 in)

43 61 62 58 64 45

48cm
(18.89 in)

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 Specifications Specifications
Performance Specifications Environmental Specifications

Illumination source High-power blue LEDs, 1-1.25W standard operating Operating Ambient temperature +10°C to +35°C
Peak wavelength 440 - 460 nm Humidity: 0% to 90% RH non condensing
Lamp duration 60,000 hours Atmospheric Pressure: 70-106kPa
Total spectral irradiance top light 40.0 µW/cm2/nm
bottom light 66.0 µW/cm2/nm Transport and storage Ambient temperature 0°C to +50°C
Effective surface area top light 48 cm x 20 cm Humidity: 0% to 90% RH non condensing
bottom light 48 cm x 20 cm Atmospheric Pressure: 70-106kPa
Relative local distribution top light 0.63 (IEC Compliant >0.4)
bottom light 0.64 (IEC Compliant >0.4) Exclusions Not for use inside an incubator
and or any radiant warmer
Time Totalizer Treatment time and total device hours
Measured with MTTS LM-800

Physical Specifications
Standards for Reference
Key features No moving parts
Enclosed designed toward NEMA Type 5 EN 60601-1:2006 + A1:2013: Medical electrical equipment – Part 1 General requirements for basic safety and
Dimensions (LxWxD) overall 66 cm x 38 cm x 49.5 cm 26in x 4.9in x 19.5in essential performance
top light 51.6 cm x 12.5 cm x 6.3 cm 0.3in x 4.9in x 2.5in
bottom light 64.7 cm x 38 cm x 10cm 25.5in x 15in x 3.9in EN 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for basic safety and es-
Total unit mass 13 kg 28.7lbs sential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests

EN 60601-2-50: 2009: Medical electrical equipment – Part 2-50: particular requirements for the basic safety
and essential performance of infant phototherapy equipment
Electrical Specifications
EN 60601-1-6:2010: Medical electrical equipment – Part 1-6: General requirements for basic safety and
Power characteristics 60W, 100-240VAC, 47/63Hz essential performance – Collateral standard: Usability
Off-the-shelf external power supply International medical safety approvals
(ANSI/AAMI/EN 60601-1, UL/TUV)
Class I construction is standard (ground required)
Biocompatibility tests
100k hours MTBF
Skin sensitization as per ISO: 10993-Part 10
Energy Star Efficiency Level V compliant
RoHS 3 compliant
Cytotoxicity direct contact as per ISO 10993-Part 5
Over voltage / over current protection

Primary skin irritation as per ISO:10993-Part 10

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 Explanation of Symbols
This statement provides important
information or highlights information that
may be easily overlooked.
This statement is a warning. Not following
this statement could result in injury to the
patient or operator, or damage to the device.
CE Marking with Notified Body Number.
2265
Do not disassemble the device unless you
are an MTTS trained technician or have been
instructed to by qualified personnel (exclud-
ing the removal of the bassinet).
Consult instructions for use or consult the
electronic insturctions for use
This device contains electronic parts. Do not
dispose of it with normal waste. Dispose of
it according to local guidelines for disposal
IPX3
of eletronics. Dispose according to the WEEE
directive in the European Union.
MD
Medical device
UDI Unique identification number
12V DC 5A
Website where a user can obtain additional
information on the medical product
VN
#
Model number
REF Catalogue number
22 V.1.14.EN
Authorized Representative in the
European Community
Device manufacturer.
Date of manufacture.
Serial number.
An eye patch should always be placed
on the patient before commencing
treatment.
Keep out of direct sunlight.
Liquid ingress protection - level 3
(spraying water).
DO NOT use Firefly phototherapy with
an MTTS infant warmer, or any other
warmer as this will cause damage to
the Firefly top light.
Power supply polarity.
12 Volts, Direct Current, 5 Ampere
Country of manufacture
Temperature limit
Humidity limitation
Atmospheric pressure limitation
Warranty Policy
General Terms
This MTTS Limited Warranty gives you, the customer,
express limited warranty rights from MTTS, the manu-
facturer for the duration specified on the Warranty Card.
Please refer to the MTTS Website for an extensive de-
scription of your limited warranty entitlements. In addi-
tion, you may also have other legal rights under applica-
ble law or special written agreement with MTTS.
MTTS makes no other express warranty or
condition whether written or oral and MTTS
expressly disclaims all warranties and con-
ditions not stated in this limited warranty.
to the extent allowed by local law of juris-
dictions outside vietnam, mtts disclaims all
implied warranties or conditions, includ-
ing any implied warranties of merchantabil-
ity and fitness for a particular purpose. for
all transactions occurring in vietnam any
implied warranty or condition of merchant-
ability, satisfactory quality, or fitness for a
particular purpose is limited to the duration
of the express warranty set forth above. some
countries do not allow a limitation on how
long an implied warranty lasts or the exclu-
sion or limitation of incidental or consequen-
tial damages for consumer products. in such
countries, some exclusions or limitations of
this limited warranty may not apply to you. for
consumer transaction, the limited warranty
terms contained in this statement, except to
the extent lawfully permitted, do not exclude,
restrict, or modify but are in addition to the
mandatory statutory rights applicable to the
sale of this product to you.
This Limited Warranty is applicable in all countries and
may be enforced in any country or region where MTTS or
its authorized service providers offer warranty service for
the same product model number (subject to the terms
and conditions set forth in this Limited Warranty)
Under this Limited Warranty, products purchased in one
country or region may be transferred to another country
or region where MTTS or its authorized service provid-
ers offer warranty service for the same product model
number. Warranty terms, service availability, and service
response times may vary from country or region to coun-
try or region. Standard warranty service response time is
subject to change due to local parts availability. If so, your
MTTS authorized service provider can provide you with
details. MTTS will not alter form, fit, or function of this
MTTS product to make it operate in a country for which
it was never intended to function for legal or regulatory
reasons. MTTS is not responsible for any tariffs or duties
that may be incurred in transferring the products.
MTTS guarantees that the product that you have pur-
chased or leased from MTTS is free from defects in ma-
terials or workmanship under normal use during Lim-
ited Warranty Period. The Limited Warranty Period starts
on the date of purchase or lease from MTTS, or from
the date MTTS completes installation. Your dated sales
or delivery receipt, showing the date of purchase of the
product, is your proof of the purchase or lease date. You
may be required to provide proof or purchase or lease as
a condition of receiving warranty service. You are entitled
to hardware warranty service according to the terms and
conditions of this document if a repair to your MTTS prod-
uct is required within the Limited Warranty Period.
Unless otherwise stated, and to the extent permitted by
local law, new MTTS product may be manufactured using
new materials and used materials equivalent to new in
performance and reliability. MTTS may repair or replace
MTTS products (a) with new or previously used products
or parts equivalent to new in performance and reliability,
or (b) with equivalent products to an original product that
has been discontinued. Replacement parts are warrant-
ed to be free from defects in material or workmanship for
ninety (90) days or, for the reminder of Limited Warranty
Period of the MTTS product they are replacing or in which
they are installed, whichever is longer.
Firefly. User manual
23
 Warranty Policy
MTTS will, at its sole discretion, repair or replace any
components or product that manifests a defect in materi-
als or workmanship during the Limited Warranty Period.
All component parts removed under this Limited War-
ranty become the property of MTTS. In the unlikely event
that your MTTS product has recurring failures, MTTS at
its sole discretion, may elect to provide you with (a) a
replacement unit selected by MTTS that is the same or
equivalent to your MTTS product in performance or (b)
to give you a refund of your purchase price or lease pay-
ments (less interests) instead of a replacement. This is
your exclusive remedy for defective products.
Exclusions
MTTS does not warrant that the operation of
this product will be uninterrupted or error-
free. mtts is not responsible for damage that
occurs as result of your failure to follow the
instructions intended for the product.
This Limited Warranty does not apply to expendable or
consumable parts and does not extend to any product
from which the serial number has been removed or that
gas been damaged or rendered defective (a) as a result
of accident, misuse, abuse, contamination, improper or
inadequate maintenance or calibration (if required) or
other external causes; (b) by operation outside the usage
parameters stated in the user documentation shipped
with the product; (c) by software, interfacing, parts or
supplies not supplier by MTTS; (d) improper site prepara-
tion or maintenance; (e) virus infection; (f) loss or dam-
age in transit ; or (g) by modification or service by anyone
other than (i) MTTS personnel, (ii) an MTTS authorized
service provider, or (iii) your own installation of end-user
replaceable MTTS or MTTS approved parts if available for
your MTTS product in the servicing country or region.
24 V.1.14.EN
Limitation of Liability
If your mtts product fails to work as warrant-
ed above, the maximum liability of mtts under
this limited warranty is expressly limited to
the lesser of the price you have paid for the
product or the costs of repair or replace-
ment of any hardware components that mal-
function in conditions of normal use.
except as indicated above, in no event will mtts
be liable for any damages caused by the prod-
uct or the failure of the product to perform,
including any lost profits or savings or spe-
cial, incidental, or consequential damages.
MTTS is not liable for any claim made by a third
party or made by you for a third party.
this limitation of liability applies whether
damages are sought, or claim made, under this
limited warranty or as a tort claim (includ-
ing negligence and strict product liability), a
contract claim, or any other claim. this limita-
tion liability cannot be waived or amended by
any person. this limitation of liability will be
effective even if you have advised mtts of the
possibility of any such damages. this limitation
of liability, however, will not apply to claims
for personal injury.
this limited warranty gives you specific legal
rights. you may also have other rights that may
vary from country to country. you are advised
to consult applicable country laws for a full
determination of your rights.
Warranty Policy
Limited Warranty Period Contacting MTTS
The Limited Warranty Period for this MTTS product is a If your MTTS product fails during the Limited Warranty
specified, fixed period commencing of the date of pur- Period and the suggestions in the product documentation
chase and specified on the Warranty Card. The date on do not solve the problem, you can receive support by do-
your sales receipt is the date of purchase unless MTTS or ing one of the following:
your reseller informs you otherwise in writing. - Locate and contact your nearest MTTS service pro-
vider via MTTS website:
Customer Responsibilities http://www.mtts-asia.com/support/
- Call the Technical Support Center:
In order to avoid the risk of charges for issues not cov- +84 43 766 6521
ered by your limited warranty (issues that are not due to Before calling MTTS or an MTTS authorized service pro-
defects in materials and workmanship on MTTS product), vider please have the following information available:
you will be asked to assist MTTS as follows: - Product serial number and model name
Verify configurations, load most recent firmware, in- - Applicable error messages
stall software patches, run MTTS diagnostics and - Detailed questions
utilities;
Implement temporary procedures or workarounds
provided by MTTS while MTTS works on permanent
solution;
Cooperate with MTTS in attempting to resolve the
problem using online chat, email, or telephone. This
may involve performing routine diagnostic procedures,
installing additional software updates or patches;
Perform additional tasks as defined within each type
of warranty service provided by MTT and any other ac-
tions that MTTS may reasonably request in order to
best perform the warranty support
Customer is responsible for delivering the
product (and all costs involved) from his lo-
cation to the MTTS authorized service point.
Firefly. User manual
25
 MEDICAL TECHNOLOGY TRANSFER AND SERVICES Co., LTD
House No. 26, Alley 41, An Duong Vuong Street, Tay Ho District, Hanoi City, Vietnam
SRN: VN-MF-000036669

Tel: +84 24 3766 6521

Fax: +84 24 3718 8050
Email: assistance@mtts-asia.com
www.mtts-asia.com

Logic s.r.l.
Via Antonio Pigafetta 1
34147 Trieste, Italy
SRN: IT-AR-000012301

V.1.14.EN